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RecruitingNCT04994665SleevepexieUpdated Sep 23, 2025

Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy

An interventional study of sleeve gastrectomy and sleeve gastrectomy with omentopexy in Obesity, sponsored by Centre Hospitalier Departemental Vendee. Recruiting at 9 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-23.

Sponsored by Centre Hospitalier Departemental Vendee · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2021; still recruiting 4 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
526
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The aim of the study is to assess impact of omentopexy on de novo gastro-oesophageal reflux disease (GERD) after sleeve gastrectomy.

This will be assess 2 years postoperatively. This study is a prospective, multicentric, randomized trial. Five hundred twenty six patients should be included with 263 in each arm. First arm will include patients who have a sleeve gastrectomy. The second arm will include patients who have sleeve gastrectomy with omentopexy.

Two years after surgery , it will be collected a CARLSSON score and BAROS score (quality of life).

The main objective is to show that omentopexy decreases the rate of de novo GERD after sleeve gastrectomy at 2 years postoperatively without the use of Proton-Pump Inhibitors (PPIs)

02

Conditions studied

  • Obesity

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Keywords

  • sleeve gastrectomy
  • omentopexy
  • gastro-oesophageal disease
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In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 526 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Centre Hospitalier Departemental Vendee is the lead sponsor of 81 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient ≥ 18 years old,
  • Patient to be operated in first intention of a sleeve gastrectomy
  • Initial BMI between 35Kg/m² and 40 Kg/m² associated with at least one severe comorbidity likely to be improved after surgery according to HAS recommendations.

OR initial BMI ≥ 40 Kg/m².

  • Multidisciplinary follow-up of at least 6 months before surgery
  • Validation of the surgical intervention in a multidisciplinary consultation meeting
  • Certificate of no contraindication by a psychiatrist
  • Patient who has the capacity to understand the protocol and has given consent to participate in the research,
  • Patient with social security coverage.

Exclusion criteria

Exclusion Criteria:

  • Eating disorder or mental disorder
  • Misunderstanding of the protocol
  • Psychiatric contraindication
  • Initial BMI \<35Kg/m².
  • Initial BMI between 35Kg/m² and 40 Kg/m² without comorbidities.
  • Esophagitis of grade B and above on the Oeso-Gastro-Duodenal Fibroscopy
  • CARLSSON score (score ≥ 4) preoperatively
  • Presence of a Proton-Pump Inhibitors treatment
  • Patient to have a 2-stage surgery (first sleeve gastrectomy then gastric bypass or Single Anastomosis Duodeno-Ileal bypass)
  • Patient participating in another interventional clinical research protocol involving a drug or medical device
  • Patient who are pregnant, breastfeeding, or who have the potential to become pregnant without effective contraception at the time of inclusion and up to 24 months after surgery
  • Patient under guardianship, curators or legal protection,P
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
526 participants (estimated)

Study arms

  • Active comparator
    Sleeve gastrectomy

    realization of a sleeve gastrectomy alone

    Procedure: sleeve gastrectomy

  • Experimental
    sleeve gastrectomy with omentopexy

    realization of a sleeve gastrectomy followed by an omentopexy

    Procedure: sleeve gastrectomy with omentopexy

Interventions

  • Proceduresleeve gastrectomy

    The sleeve gastrectomy is a surgical weight-loss procedure, about 80% of the stomach is removed

  • Proceduresleeve gastrectomy with omentopexy

    After sleeve gastrectomy procedure, the omentopexy involves suturing the omentum back to the greater curvature of the stomach in several locations, depending on the length of the greater curvature

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What researchers measure

Primary outcomes

  1. Evaluate de novo GERD of patient benefited from sleeve gastrectomy with omentopexy versus sleeve gastrectomy alone

    Presence of de novo GERD defined by a clinical score of CARLSSON \>= 4 and/or the use of a PPIs treatment

    Time frame: 2 years postoperatively

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Study locations

8 of 9 sites recruiting
  • CH de la Cote Basque
    Bayonne, France
    • Renaud GONTIER, Dr · Principal investigator
    Recruiting
  • CHD Vendée
    La Roche-sur-Yon, 85000, France
    • Emeric ABET, Dr · Principal investigator
    Recruiting
  • Centre Hospitalier Emile Roux
    Le Puy-en-Velay, 43012, France
    • Luis Matias BRUNA · Principal investigator
    Recruiting
  • CHU Nantes
    Nantes, 44000, France
    • Claire BLANCHARD, Dr · Principal investigator
    Recruiting
  • Clinique Jules Verne
    Nantes, 44300, France
    • Laurent POTIRON · Principal investigator
    Recruiting
  • Centre Hospitalier Régional et Universitaire d'Orléans
    Orléans, France
    • Adel ABOU-MRAD, Dr · Principal investigator
    Recruiting
  • Hopital Pontchaillou
    Rennes, 35000, France
    • Marie LIVIN, Dr · Principal investigator
    Recruiting
  • Clinique Mutualiste de la Sagesse
    Rennes, France
    • Damien BERGEAT, Dr · Principal investigator
    Not yet recruiting
  • Clinique Santé Atlantique
    Saint-Herblain, 44800, France
    • Antoine SINA, Dr · Principal investigator
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04994665
Lead sponsor
Centre Hospitalier Departemental Vendee
Responsible party
Sponsor
First posted
Aug 6, 2021
Start date
Dec 7, 2021
Primary completion
Nov 1, 2027 (estimated)
Completion
Nov 1, 2028 (estimated)
Last update
Sep 23, 2025

Study contacts

Agnès Dorion
Contact
agnes.dorion@chd-vendee.fr
251446380 ext. +33
Emeric Abet, Dr
principal investigator · CHD Vendée

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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